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Prescription Digital Therapeutics

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Europe vs the US: New drug product approvals

As US approvals rates in the US drop,  the EU is not currently showing a similar trend

- PMLiVE

EMA and FDA calls for innovative approaches for Gaucher disease medicines

The regulatory agencies also urge a similar method for all paediatric diseases

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FDA moves to tackle orphan designation backlog

Some 200 requests are awaiting review by the US regulator

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FDA panel backs CV claims for Novo Nordisk’s Victoza

LEADER trial shows the diabetes treatment reduces risk of cardiovascular death by 13%

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Sandoz joins Europe’s MabThera biosimilar push

Novartis’ unit is second company to claim approval in Europe for biosimilar version

Bayer symbol

Bayer wins FDA approval for MS electronic autoinjector and app

US regulator gives green light to Betaconnect and myBETA app

Eli Lilly HQ

FDA fast-tracks Pfizer and Lilly’s tanezumab

The novel pain drug treats osteoarthritis and chronic low back pain

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Novo Nordisk’s long-acting haemophilia B drug cleared by FDA

US approval sets up marketing battle with Bioverativ and CSL Behring

Novartis building

Novartis’ Zykadia claims US approval for first-line lung cancer

The Swiss pharma giant’s drug also receives CHMP positive opinion

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FDA panel backs Puma’s breast cancer drug, with reservations

Side effects concerns could see medicines limited

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Keytruda is first FDA-approved drug for molecular indication

Indicates a significant development in the shift towards personalised medicine

Sanofi reception

Sanofi/Regeneron’s Sarilumab cleared by FDA on second attempt

IL-6 inhibitor to treat adult RA patients

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